eudamed_udi Primary ID: 86979834610313

Malaria Test Device(whole blood) (UDI 86979834610313)

Manufactured by Neo-nostics (Suzhou) Bioengineering Co., Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Malaria Test Device(whole blood) (Model/Catalog Number: MAL0238) is a medical device manufactured by Neo-nostics (Suzhou) Bioengineering Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105090499 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MAL0238
Product Code / EMDN: W0105090499
Device Name: Malaria Test Device(whole blood)
Database Sync Date: 2026-08-09 16:29:12

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Malaria Test Device(whole blood)?

The registered manufacturer of record for Malaria Test Device(whole blood) is Neo-nostics (Suzhou) Bioengineering Co., Ltd..

What is the Primary UDI-DI identifier for Malaria Test Device(whole blood)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 86979834610313.

What classification code is assigned to this device?

This device is registered under product classification code W0105090499.

Similar Classification Devices (W0105090499)

Other Devices by Neo-nostics (Suzhou) Bioengineering Co., Ltd.

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